510(k) K171257 ยท ORR Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
ClearPoint System
| Applicant | Mri Interventions, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 20, 2017 |
| Received | Apr 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171257
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.